ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001049369

Ethics application status

Approved

Date submitted

18/06/2017

Date registered

18/07/2017

Date last updated

4/06/2019

Date data sharing statement initially provided

3/04/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

comparison of umbilical venous catheter versus central lines in incidence of brain hemorrhage in preterm infants

Scientific title

Does the use of peripherally inserted central catheters compared to umbilical venous catheter reduce the incidence of brain hemorrhage in preterm infants?

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1198-0699

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

intraventricular hemorrhage in preterm infants

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Neurological

Other neurological disorders

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome.
Different contributing etiologies have been studied to explain the cause of IVH.
Umbilical venous catheter (UVC) and peripherally inserted central catheters (PICC) are routinely used interchangeably in preterm infants for central venous access.
The purpose of this study is to compare the incidence of IVH-PVH in preterm infants using UVC versus those with PICC.
200 preterm infants admitted to NICU, Dubai Hospital will be enrolled prospectively in this study with 100 infants in each arm (UVC group and PICC group).
Gestational age of infants will be ranging from 24 to 30 weeks with a mean of 27 weeks.
The protocol of NICU is to insert UVC or PICC routinely after stabilization of sick preterm infants for proper administration of medications and parenteral nutrition. UVC or PICC insertion is done after admission to NICU by A well trained neonatologist registrar on call and kept for a total duration of 7-10 days for the UVC and for 2-3 weeks for PICC.
Cranial ultrasound scan will be carried on all infants in the two groups as per NICU policy, first scan on day 3 – 7, second scan on day 10-14 and third on 34-36 weeks GA and or before discharge.
IVH-PVH grading and associated complications of periventricular leukomalacia PVL and post- hemorrhagic ventricular dilatation PHVD will be recorded for both groups.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Intervention code [3]

Treatment: Devices

Comparator / control treatment

UVC group compared to PICC group.

Control group

Active

Outcomes

Primary outcome [1]

Does PICC insertion reduces the incidence of IVH in preterm infants compared to UVC as detected by brain ultrasound scan?

Timepoint [1]

3 days post insertion of central line. then 10 days after central line insertion.
Third scan will be carried out at 34-36 weeks GA.

Secondary outcome [1]

. periventricular leukomalacia (PVL).
Detected by cranial ultrasound examination .

Timepoint [1]

4 weeks post insertion of central line.

Secondary outcome [2]

post-hemorrhagic ventricular dilatation.
Assessed by cranial ultrasound scan.

Timepoint [2]

4 weeks post insertion of central line.

Secondary outcome [3]

central line associated late onset sepsis.
Assessed by blood culture.

Timepoint [3]

1 week after central line insertion.

Eligibility

Key inclusion criteria

All preterm infants with gestational age ranging from 24- 30 weeks admitted to NICU Dubai hospital

Minimum age

1 Hours

Maximum age

4 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1- infants with major congenital abnormalities.
2-infants with antenatal diagnosis of IVH or congenital hydrocephalus.
3-infants more than 30 weeks gestation.
4- infants with bleeding disorders.
5-infants born outside the hospital.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

concealment by sealed opaque envelops.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified allocation using gestational age

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

sample size determined based on admission rate of preterm infants less than 30 weeks in NICU Dubai hospital during the trial period of 12 month.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

25/07/2017

Actual

25/07/2017

Date of last participant enrolment

Anticipated

1/08/2019

Actual

Date of last data collection

Anticipated

31/08/2019

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment outside Australia

Country [1]

United Arab Emirates

State/province [1]

dubai

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

dubai hospital

Address [1]

NICU, Dubai Hospital. third floor. Albaraha, Alkornisch street No.1. Dubai, 7272 UAE.

Country [1]

United Arab Emirates

Primary sponsor type

Individual

Name

Atef Alshafei

Address

NICU, Dubai Hospital
Third floor,
Albaraha , Alkornisch street No.1.
Dubai 7272.
UAE.

Country

United Arab Emirates

Secondary sponsor category [1]

Hospital

Name [1]

Dubai Hospital

Address [1]

NICU, Dubai Hospital,
Third floor.
ALlbaraha, Alkornisch street No.1.
Dubai 7272.
UAE.

Country [1]

United Arab Emirates

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Dubai scientific research ethics committee DSREC

Ethics committee address [1]

DSREC 
continuous medical education department.
 Rashid medical library.
 Po Box  4545 
Dubai. UAE.

Ethics committee country [1]

United Arab Emirates

Date submitted for ethics approval [1]

05/01/2017

Approval date [1]

24/05/2017

Ethics approval number [1]

DSREC-03/2017_05

Summary

Brief summary

Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome.
The etiology of IVH is multifactorial and attributed mainly to disturbance of cerebral blood flow.
Placing UVC shortly after birth would keep ductus venosus opened and simulate the unique preferential blood flood flow of fetal circulation via inferior vena cava to the right atrium and then patent foramen ovale PFO to the left atrium. This would directly influences the cerebral blood flow stability in that subset of infants with a limited cerebral autoregulation.
This does not happen under physiological conditions with drop of pulmonary blood pressure soon after birth and reverse of shunt through PFO from left to right.
In sick preterm infants with RDS and variable degrees of hypoxemia, the pulmonary pressure remains at higher levels for considerable time with occasional right to left or bidirectional shunt.
On the other hand, placing PICC instead would avoid the direct pathway through PFO to left atrium and eventually to the brain. Accordingly, in this way it could theoretically reduce the incidence of IVH by avoiding the swinging of cerebral blood flow.
This  prospective study will be conducted at NICU, Dubai hospital. Dubai, UAE.
200 preterm infants with gestational age ranging from 24 to 30 weeks (mean GA 27 weeks) and weight range from 500 Gm to 1500 Gm. will be enrolled in the study, 100 infants in each arm (UVC group and PICC group). NICU registrar on call will  open a sequentially numbered, sealed, opaque envelope indicating the treatment arm, either UVC or PICC insertion.
Demographic data including GA, weight, gender, antenatal steroids, mode of delivery, Apgar score, resuscitation, mode of ventilation support, hemodynamic stability, and surfactant administration will be considered equally on assignment of infants to either group.
Routine cranial ultrasound will be carried out by trained neonatologists according to NICU policy, first scan on day 3 – 7, second scan on day 10-14 and third on 34-36 weeks GA and before discharge.to check the presence of IVH, the grade, and associated complications PVL or post -hemorrhagic ventricular dilatation.
Statistical analysis of collected data comparing the two groups will be carried on to answer the question if central lines insertion is superior to UVC in decreasing the incidence of IVH in sick preterm infants in the first 2 weeks of life.as primary outcome .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr atef alshafei

Address

NICU,
Dubai hospital, third floor,
Albarah, Alkornish street .No.1.
Dubai, 7272
UAE.

Country

United Arab Emirates

Phone

+971561924270

Fax

ahalshafei@dha.gov.ae

Contact person for public queries

Name

atef alshafei

Address

NICU,
Dubai hospital, third floor,
Albarah, Alkornish street .No.1.
Dubai, 7272
UAE.

Country

United Arab Emirates

Phone

+971561924270

Fax

ahalshafei@dha.gov.ae

Contact person for scientific queries

Name

atef alshafei

Address

NICU,
Dubai hospital, third floor,
Albarah, Alkornish street .No.1.
Dubai, 7272
UAE.

Country

United Arab Emirates

Phone

+971561924270

Fax

ahalshafei@dha.gov.ae

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial.

When will data be available (start and end dates)?

One month following main results publication. No end dates.

Available to whom?

case by case basis

Available for what types of analyses?

Any purpose

How or where can data be obtained?

access subject to approvals by Principal Investigator

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Association of umbilical venous catheters vs peripherally inserted central catheters with death or severe intraventricular hemorrhage among preterm infants < 30 weeks: A randomized clinical trial.	2023	https://dx.doi.org/10.3233/NPM-221126

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically